Key result
In 36 clinical implants of the Sorin Bicarbon bileaflet valve in the mitral position, the mean diastolic gradient was 4 mmHg with no leaflet fracture or thromboembolic complications at 15 months.
Why the study?
Does the Sorin Bicarbon bileaflet valve provide adequate hemodynamic performance and safety in preclinical and clinical settings?
Population
33 sheep (tricuspid implantation) and 36 clinical patients receiving mitral valve replacement (size 29)
Design
Case_series
Follow-up
15 months (clinical), 40-400 days (preclinical)
Authors
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Supports further evaluation of the Sorin Bicarbon mitral valve; Level 5 evidence leaves its role in practice open pending larger studies.
Cohort (n=36)
Does the Sorin Bicarbon bileaflet valve provide adequate hemodynamic performance and safety in preclinical and clinical settings?
The Sorin Bicarbon bileaflet valve demonstrated favorable hemodynamics and no thromboembolic complications in early preclinical and clinical evaluation.
Vallana et al. (1992) conducted a cohort in Mitral valve disease (n=36). Sorin Bicarbon bileaflet valve was evaluated on Mean diastolic gradient, functional area, and clinical complications. In 36 clinical implants of the Sorin Bicarbon bileaflet valve in the mitral position, the mean diastolic gradient was 4 mmHg with no leaflet fracture or thromboembolic complications at 15 months.
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